A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Immune response to GI-4000
研究概览
简要总结
This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.
详细描述
NSCLC is the deadliest form of human cancer, killing approximately 150,000 people a year in the United States. The best treatment for NSCLC is surgical resection. For patients with inoperable or unresectable NSCLC chemotherapy and radiation is used as first line therapy. This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment. These subjects must also have a ras mutation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven stage I-III NSCLC
- •Confirmed product related ras mutation
- •ECOG performance status of less than or equal to 2
- •greater than or equal to 18 years of age
排除标准
- •History of a previous cancer
- •History of splenectomy
- •History of Crohns disease or ulcerative colitis
- •History of major organ transplantation
- •Concurrent or chronic steroid therapy
- •History of allergy to yeast
- •Presence of an unstable or poorly controlled medical condition
- •Pregnant or nursing mothers
- •Positive skin test to yeast
结局指标
主要结局
Immune response to GI-4000
时间窗: 2 years
次要结局
未报告次要终点
